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510(k) K232835

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System by Canon Medical Systems Corporation — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2024
Date Received
September 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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Other clearances for product code JAK

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  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)